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OpenTrials
Completed

NCT Number: NCT01263262

A Comparison of Infection Rates Between Two Surgical Sites

Does the use of chlorhexidine scrub prior to cutaneous surgery on the face increase the chances of toxicity to the eyes or ears? In addition, does the us eof chlorhexidine scrub on the face prior to cutaneous surgery decrease the chances of a post-operative wound infection?

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Key information

About this study

The intent of this proposed prospective observational cohort study is to determine if there is a difference in the incidence of corneal toxicity and/or ototoxicity in study subjects undergoing Mohs micrographic surgery (MMS) on the face if a povidone-iodine preparation is used pre-operatively as compared to a chlorhexidine-alcohol preparation. It has recently been found that the use of a chlorhexidine-alcohol preparation is superior to the use of a povidone-iodine preparation in preventing post-operative surgical-site infections (SSI) in patients undergoing clean-contaminated surgery. However, the use of chlorhexidine on the face has previously been associated with corneal toxicity and ototoxicity. This study will help to further define previously reported risks of corneal toxicity and ototoxicity associated with the use of a chlorhexidine solution on the face.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing an outpatient cutaneous surgical procedure on the face.

Exclusion criteria

  • Those who do not consent to participation
  • Those undergoing cutaneous surgery for a lesion on the eyelid margin
  • Patients with a history of ongoing eye pain
  • History of a pre-existing corneal ulcer within 12 months prior to surgery
  • History of a perforated tympanic membrane
  • Patients with an active infection at the surgical site at the time of surgery.
  • If post-operative follow-up is not completed, the study subject will be excluded from the analysis.

Treatment and study plan

Primary outcomes

  1. Ocular and Ear Toxicities

    Time frame: 1 year

    Comparing ocular and ear toxicities between two institutions with differences in aseptic technique.

Secondary outcomes

  1. Infection rates

    Time frame: 1 year

    compare the infections rates between two institutions with different skin prep practices

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • University of Toronto

Registry information

Official study title

A Comparative Assessment Between Two Surgical Sites of the Rate of Corneal Toxicity and Ototoxicity With the Use of Povidone-iodine Versus Chlorhexidine-alcohol for Facial Lesions Treated With Mohs Micrographic Surgery

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 20, 2010
Registry last updated
Oct 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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